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IRCT20210227050510N1 IRCT 2021-07-13 Rasht University of Medical Sciences An evaluation of the effect of albumin administration time on the incidence of fluid creep in severe burn patients A comparison of the effect of receiving albumin in the initial 8 to 12 hours and after 24 hours after burn on the incidence of fluid creep in severe burn patients 2021-07-23 anticipated 96 Complete https://irct.ir/trial/56651 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In the presenting study, we employ categorized randomization. We classify the minimum sample size according to the existence of inhalation injury and burn surface area. To randomize the patients into intervention and control groups, we use restricted randomization with block randomization. We use randomized 2 or 4 member blocks to prevent revealing the last allocation in each block. Patients entering the study after completion of each block will enter new 2 or 4 member blocks. We classify patients according to burn surface area into 5 groups with 20-25, 25-30, 30-35, 35-40, and more than 40 percent total body surface area burn, and regarding inhalation injury into 2 groups having or not having inhalation injury, Blinding description: Albumin will be infused into the patient's resuscitation fluids and the patient is not going to be aware of the time of albumin infusion. Data collection is done by observing team members that are not aware of the patient's allocation to either intervention or control groups, using the designed checklist. Data analysis is performed by the specialist that is not aware of A and B coding (and that which one is the intervention group). 3 Burn. Intervention 1: Intervention group: The intervention group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn between 8 to 12 hours after admission as a 1-hour infusion. Intervention 2: Control group: The control group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn after 24 hours post-admission as a 1-hour infusion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is no more information is available.
public Mohammadreza Mobayen
Velayat Hospital, Namjou St., Rasht
Rasht Iran (Islamic Republic of) 4193713191 +98 13 3336 9633 mmobayen@gums.ac.ir Rasht University of Medical Sciences scientific Mohammadreza Mobayen
Velayat Hospital, Namjou St., Rasht
Rasht Iran (Islamic Republic of) 4193713191 +98 13 3336 9633 mmobayen@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) burn patients with 2nd and 3rd degree burn area more than 20 percent TBSA full-thickness burn area more than 10 percent TBSA patients needing vasopressor usage in the first 24 hours of admission patients needing intubation and mechanical ventilation in the first 24 hours of admission 1 year no limit Both patients not needing albumin infusion according to the clinical decision of specialist critically ill patients with expected death in first 24 hours or patients that expired in first 24 hours of admission brain death in first 24 hours patients admitted more than 8 hours after burn patients with chronic underlying diseases affecting serum albumin level, including nephrotic syndrome, cirrhosis, malnutrition, exudative enteropathy pregnancy a history of cardiac surgery or myocardial infarction in recent 5 years patients with high-voltage electrical burn injuries patient does not accept entering the study patients receiving plasmaphresis a history of reaction to human albumin T31 Burns classified according to extent of body surface involved Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn between 8 to 12 hours after admission as a 1-hour infusion. Control group: The control group will receive 20% human albumin 0.125 milliliters per kilogram body weight per percent body surface burn after 24 hours post-admission as a 1-hour infusion. Fluid creep, patient's fluid intake exceeding estimated intake with parkland formula. Timepoint: 12 hours and 1,2,3,5, and 7 days after-burn. Method of measurement: assessment of the fluid intake of patient to maintain a satisfactory urine output. Length of hospital stay. Timepoint: At the time of hospital discharge. Method of measurement: Days. Rasht University of Medical Sciences Approved 2021-06-02 Ethics Committees of Guilan university of medical sciences Deputy of Research and Technology of Guilan University of Medical Sciences, Siyadati St., Namjou Blvd., Rasht Rasht Guilan Iran (Islamic Republic of)